Research - Laboratory/Non-Laboratory, Staff/Administrative
A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
As an integral member of the research team, the Clinical Research Coordinator (CRC) will help ensure that clinical research studies at the University of Michigan Obstetrics and Gynecology Department and are initiated and executed in the highest quality and compliant manner. In order to succeed, the applicant must possess exceptional organizational skills, uncompromising integrity, a love of people, and a strong willingness to learn new skills. The research coordinator may be assigned to more than 1 project or have overlapping duties with other team members.
Candidate will be responsible for assisting with all aspects of the project, including the development of study protocols, participant enrollment and follow-up, training and managing research assistants and other project staff, tracking and managing project data, and drafting progress reports. The candidate will work closely with the Principal Investigator, Co-Investigators, and other members of the research team.
CRC will act as liaison between study team and sponsors, IRB, federal, state, university officials, and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues. Serve as key resource to research participants and collaborators. Provide support for audits and monitor visits.
RECRUITMENT: The CRC will work with the investigators in order to recruit and retain study participants. CRC will assist study teams with aspects of clinical trial coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects.
PROTOCOL SPECIFIC NEEDS: Broad research and technical skills are needed in nearly every clinical research trial (e.g. capturing and reporting adverse events, identifying and reporting serious adverse events, protocol deviations, resolving queries, IVRS/IWRS, Imaging needs of study, etc.). Each clinical trial will have a unique protocol, study needs, study population, etc. The CRC is expected to possess a willingness to learn protocol specific testing requirements and administer surveys.
Investigational product coordination experience is desired.
SPECIMEN COLLECTION: Collect specimens and monitor study subjects. Assist in monitoring of test results. Ensure integrity of specimens (collection, processing, shipping, storing, labeling, tracking, etc.).
SUBJECT COMPENSATION: Administer and provide subject compensation using HSIP.
DATA: The CRC will help carry out data acquisition through various testing modalities (e.g. collection specimen or products, dispensing of products, survey administration on sensitive reproductive and women’s health topics, etc.), inputting data into case report forms (CRFs), maintaining studies in the OnCore clinical trial management system and other electronic data capture systems (EDC), and resolving queries.
Perform data management and results reporting, assist with collection of external medical records for study reporting purposes. Ability to identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs) to the IRB in a timely fashion. Coordinate monitor visits.
TEAMWORK: Staff members are expected to work independently when appropriate and in a team based environment; sharing pertinent information in a clear and timely fashion for smooth team operations.
Regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while maintaining the strictest of confidentiality at all times.
REGULATORY COMPLIANCE: Prepare IRB submissions including the initial applications, as well as amendments and scheduled continuing reviews, progress reports, safety reports, deviation, and adverse event reports.
Be knowledgeable and follow all local, state, and federal regulations regarding clinical research in addition to Good Clinical Practice and protocol specific guidelines. The CRC is expected to actively support an environment of strict regulatory compliance.
COMMUNICATIONS: The CRC is expected to facilitate communications between sponsors and contract research organizations, research volunteers, investigators, regulatory personnel, and other key contributors. The communications will include but are not limited to scheduling appointments, interfacing with the regulatory and financial authorities, working closely with study monitors, and problem solving.
STUDY COORDINATIOIN WITH EXTERNAL SITE: Coordinate with enrolling site on projects as needed. Communicate with enrollment site concerning progress of clinical studies, issues, subject related problems, recruitment strategies, and specific policies and procedures. Take initiative and ownership of study documents, procedure manuals, and SOPs development and updates. Support manuscript writing discussions and data analysis.
Work collaboratively with the CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients.
TEAM SUPERVISION: In conjunction with Operations Manager support with supervision of the study team of patient recruiters. Assist with monitoring of daily tasks - scheduling, attendance and time reporting. Identify and recommend staffing needs; Support with hiring; Train new staff. Responsible for directing daily work and directing team.
OTHER: The CRC is expected to incorporate regulatory and research changes as they occur. In addition, the CRC might be asked to become proficient with phlebotomy.
At least a bachelor's degree (or equivalent) with at least 2 years related experience in clinical research is required in the areas of study coordination (data management and/or regulatory compliance with IRBs) with human subjects research.
Participant recruitment experience along with proficiency with multiple areas of study coordination and management, including supervising personnel, managing work relationships, and developing and managing databases.
Knowledge of general clinical research operations and regulations; familiarity with identifying and reporting AE/SAE and deviations.
Experience Computer keyboard proficiency; experience in REDCap, Canva, Qualtrics, and proficient in MS Office applications.
Exceptional organizational skills; Critical thinking and problem solving abilities are required.
Capacity to learn new skills as the positional needs change.
Ability to work both independently and as part of a team.
Experience with MS Word, Excel, Power Point, Outlook or equivalent.
Preferred Master's degree or equivalent in clinical research.
Highly preferred 2-5 years’ experience in clinical research with human subjects, with preference toward an applicant with experience conducting a randomized controlled trial, and managing regulatory protocols for work with human subjects.
Previous experience with RedCap, Canva, Qualtrics, and other applications Experience with Epic electronic health record (EHR) system.
Willingness to achieve professional certification such as SOCRA or equivalent.
Prior experience with hiring and managing staff is preferred.
Prior experience with clinical research in Women’s Heath and Ob/Gyn is preferred.
Preferred proficiency in all aspects of data management and results reporting.
Experience with the OnCore clinical trial management system (CTMS)
The candidate for this position must be able to:
Work well independently; Work flexible hours to accommodate recruitment.
M-F 8am-5pm; This will be a full-time position located at University of Michigan University Hospital and may require some evenings/weekends at the hospital or a satellite clinic.
Demonstrate a strong ability to establish rapport with individuals at all levels across multiple fields.
Demonstrate a strong ability to keep accurate and detailed project records.
2 year term-limited position
This is a grant funded appointment with opportunity for extension should funding allow. At the end of the stated term, the appointment will terminate and will not be eligible for Reduction in Force (RIF) benefits.
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 180722
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.